Status:
TERMINATED
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
Lead Sponsor:
Gemini Therapeutics, Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Retinal Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.
Detailed Description
This is a Phase 2a, multi-center, multiple dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) to investigate the safety and tolerability of GEM103 IVT injection + standard...
Eligibility Criteria
Inclusion
- At least 50 years old at the time of signed informed consent
- Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center
- Maximum CNV lesion size of 12 disc areas
- Subretinal hemorrhage less than or equal to (\<=) 50% of lesion size
- On aflibercept treatment prior to Day 1
- Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS
Exclusion
- Presence of the following ocular conditions in the study eye:
- Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections
- Any intraocular surgery
- Aphakia or complete absence of the posterior capsule
- Prior corneal transplant
- Scar or fibrosis greater than or equal to (\>=) 50% of CNV lesion or involving center of fovea
- Presence of any of the following ocular conditions in either eye:
- History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy
- Concurrent disease that could require medical or surgical intervention during the study period
- Active/suspected ocular/periocular infection or active intraocular inflammation
- History of idiopathic or autoimmune-associated uveitis
- Any prior or ongoing medical condition or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
- Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent
- Females must not be pregnant or lactating
- Current use of medications known to be toxic to the lens, retina or optic nerve
- Use of any investigational new drug or other experimental treatment in the last 6 months prior to Day 1, and/or receipt of any prior gene therapy or ocular device implantation
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04684394
Start Date
December 29 2020
End Date
February 18 2022
Last Update
October 31 2022
Active Locations (23)
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1
Gemini Clinical Trial Site 16
Phoenix, Arizona, United States, 85021
2
Gemini Clinical Trial Site 11
Campbell, California, United States, 95008
3
Gemini Clinical Trial Site 9
Encino, California, United States, 91436
4
Gemini Clinical Trial Site 17
Huntington Beach, California, United States, 92647